International teleproctoring in neurointerventional surgery and its potential impact on clinical trials in the era of COVID-19: legal and technical considerations

Abstract

BackgroundExisting travel restrictions limit the mobility of proctors, significantly delaying clinical trials and the introduction of new neurointerventional devices. We aim to describe in detail technical and legal considerations regarding international teleproctoring, a tool that could waive the need for in-person supervision during procedures.MethodsInternational teleproctoring was chosen to provide remote supervision during the first three intracranial aneurysm treatments with a new flow diverter (currently subject of a clinical trial) in the US. Real-time, high-resolution transmission software streamed audiovisual data to a proctor located in Canada. The software allowed the transmission of images in a de-identified, HIPAA-compliant manner.ResultsAll three flow diverters were implanted as desired by operator and proctor and without complication. The proctor could swap between images from multiple sources and reported complete spatial and situational awareness, without any significant lag or delay in communication. Procedural times and radiologic dose were similar to those of uncomplicated, routine flow diversion cases at our institution.ConclusionsInternational teleproctoring was successfully implemented in our clinical practice. Its first use provided important insights for establishing this tool in our field. With no clear horizon for lifting the current travel restrictions, teleproctoring has the potential to remove the need for proctor presence in the angiography suite, thereby allowing the field to advance through the continuation of trials and the introduction of new devices in clinical practice. In order for this tool to be used safely and effectively, highly reliable connection and high-resolution equipment is necessary, and multiple legal nuances have to be considered.

Remote neuro-endovascular consultation using a secure telemedicine system: A feasibility study

“…Using this system, trainees can learn the endovascular cutting-edge technique using their own monitoring system, such as the iPad. A similar system was reported by Orru et al [6] for endovascular proctoring purposes in the United States and Canada. In their system, images were controlled by the operator site, not the proctor site.…”

“…A similar system was reported by Orru et al . [ 6 ] for endovascular proctoring purposes in the United States and Canada. In their system, images were controlled by the operator site, not the proctor site.…”

Change is everything

“…A welcome derivative of our sequestration was the development of virtual meeting platforms and telemedical outreach to our patients. As we gradually emerge from the pandemic and re-emerge into personal interaction, these virtual venues remain important mechanisms to promote global medical participation and enhance patient care 5. Virtual interaction also allows investigators to continue scientific trials, while also facilitating access to novel devices and techniques 6.…”

“…Virtual interaction also allows investigators to continue scientific trials, while also facilitating access to novel devices and techniques 6. Global teleproctoring initiatives could potentially enable neurointerventionalists in remote areas with limited resources to perform complex cases and use novel technology under live supervision 5. Similarly, the advent of robotic neurointervention offers the tantalizing prospect of performing procedures remotely 7.…”

COVID-19 meets neurointervention on the pages ofJNIS

“…Several groups assessed the feasibility of teleproctoring and its impact on various elements of practice, including clinical trials. 19 Telehealth had been a challenging area historically for a variety of reasons, including reimbursement. The pandemic accelerated trends and Lun et al found that virtual clinics were preferred by patients and physicians alike for non-urgent follow-up appointments.…”